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Completed

NCT Number: NCT01439009

Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients

One tolvaptan 15 mg tablet or placebo tablet will be orally administered once daily in the morning for up to 14 days to heart failure patients with volume overload that does not show adequate response to other diuretics such as loop diuretics in order to investigate the effect of tolvaptan on the mid- to long-term prognosis of the target population. The efficacy of tolvaptan during the treatment period will also be investigated.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Edema Heart Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chube Region, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients from whom informed consent has been properly obtained in writing prior to start of the trial
  • Patients who have been clinically diagnosed with heart failure
  • Patients with any of the following conditions or symptoms: lower limb edema, dyspnea, jugular venous distension, hepatomegaly, pulmonary rales, third heart sound, or pulmonary congestion
  • Patients who have been receiving loop diuretics, thiazide diuretics, or anti-aldosterone diuretics
  • Male or female patients of age 20 to 85 years inclusive (at time of informed consent)
  • Patients who, together with their partner(s), are able to use an appropriate method of contraception until 3 months after final trial drug administration
  • Patients who are able to be hospitalized at the trial site for at least 7 days from the start of trial drug administration

Exclusion criteria

  • Patients with a history of hypersensitivity to any ingredient of the drug or to tolvaptan analogues (e.g., mozavaptan hydrochloride)
  • Patients with anuria
  • Patients who cannot sense thirst or who have difficulty with fluid intake
  • Patients with hypernatremia (serum sodium concentration > institutional upper limit of normal) 5) Female patients who are pregnant, possibly pregnant, or nursing
  • Patients judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial due to any of the following conditions or symptoms:
  • Hyponatremia (serum sodium concentration < 125 mEq/L)
  • Serious coronary artery disease or cerebrovascular disease
  • Hyperkalemia
  • Severe renal disorder
  • Poorly controlled diabetes mellitus
  • Severe hepatic disease
  • Impaired urinary excretion due to urinary stenosis, calculus, or tumor
  • Cardiac valve disease with significant heart valve stenosis
  • Malignant tumor of unfavorable prognosis
  • Patients with suspected hypovolemia
  • Patients with an implanted circulatory support device
  • Patients in whom acute cardiac infarction occurred within 30 days prior to the screening examination
  • Patients who participated in any other clinical trial or postmarketing clinical trial within 30 days prior to the date of informed consent for the present trial
  • Patients who received tolvaptan within 26 weeks prior to the date of informed consent
  • Patients who are otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the trial

Treatment and study plan

Tolvaptan

Drug

Once-daily oral administration of one tolvaptan 15 mg tablet in the morning

Placebo of tolvaptan

Drug

Once-daily oral administration of one placebo tablet in the morning

Primary outcomes

  1. Cummulative Incidence of Events at Week 26

    Time frame: Week 26

    From start day of IMP administration to final day of follow up period, 1) and 2) below were defined as event

    • Death from cardiovascular events
    • Worsening of heart failure
    • The day of re-hospitalization due to worsening of heart failure
    • The day of medication below due to worsening of heart failure Phosphodiesterase III inhibitors (Injection), Catecholamine preparations (Injection), Colforsin preparations (Injection), Diuretics (Injection), Human atrial natriuretic peptide preparations (Injection)：Calperitide (Injection)

  2. Mortality （Number of Death）

    Time frame: Week26

    Statistical comparison was not done.

  3. Body Weight

    Time frame: Day15

    The comparison of the average of amount of change from baseline. Statistical comparison was not done.

  4. Number of Subjects Whose Lower Limb Edema Severity Grading Improved by One or More Grade

    Time frame: Day15

    Of the subjects who had lower limb edema at baseline, the number of subjects whose lower limb edema severity grading. Statistical comparison was not done.

  5. Jugular Venous Distension

    Time frame: Day15

    The comparison of the average of amount of change from baseline. Statistical comparison was not done.

  6. Change in Liver Size From Baseline

    Time frame: Day15

    The comparison of the average of amount of change from baseline. Statistical comparison was not done．

  7. Pulmonary Rales

    Time frame: Day15

    Of the subjects who had pulmonary rales at baseline, the number of subjects whose symptom was resolved at completion of treatment. Statistical comparison was not done.

  8. Third Heart Sound

    Time frame: Day15

    Of the subjects who had third heart sound at baseline, the number of subjects whose symptom was resolved at completion of treatment. Statistical comparison was not done.

  9. Cardiothoracic Ratio

    Time frame: Day15

    Investigator majored Thoracic length and Cardiac length from chest X-ray. Cardiothoracic Ratio was calculated from Cardiac length/Thoracic length*100. Lowering of Cardiothoracic Ratio suggests recovery from heart congestion.

    The comparison of the average of amount of change from baseline. Statistical comparison was not done.

  10. Pulmonary Congestion

    Time frame: Day15

    Of the subjects who had pulmonary congestion at baseline, the number of subjects whose pulmonary congestion severity grading showed an improvement of one grade or more (eg, moderate to mild) at completion of treatment. Statistical comparison was not done.

  11. Plasma Brain Natriuretic Peptide (BNP) Concentration

    Time frame: Day15

    The comparison of the average of amount of change from baseline. Statistical comparison was not done.

  12. Dypnea

    Time frame: Day15

    Of the subjects who had dyspnoea at baseline, the number of subjects whose symptom was resolved at completion of treatment. Statistical comparison was not done.

  13. Number of Subjects Whose New York Heart Association (NYHA) Classification Improved by One More Grade From Baseline

    Time frame: The day after last IMP administration and Baseline

    New York Heart Association (NYHA) Classification is below ClassI：No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

    ClassII：Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

    ClassIII：Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

    ClassIV：Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multi-center,_double-blind,_pararel-group Comparison Trial to Investigate the Effect of Short-term Administration of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients (Phase_4 Study)

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 22, 2011
Registry last updated
Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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