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NCT Number: NCT01752543

Effects on Exercise Hemodynamics of Vasopressin Blockade by Conivaptan Infusion in Heart Failure Patients

The purpose of the present study is to evaluate the effects of a blockade of the vasopressin system and central hemodynamic system in heart failure (HF) patients during physical exercise. The significance of the vasopressin system during physical exercise is unclear. If vasopressin is a significant regulator of exercise hemodynamics in HF, strategies to intervene against activation of the V1A-receptor might be expected to improve HF symptoms and possibly outcome.

The potential effects of the central hemodynamic system will be evaluated with a Swan-Ganz catheter. Echocardiography will be performed at rest and during submaximal working capacity before and during the infusion of a vasopressin receptor antagonist (conivaptan) or placebo. Cardiac output will be measured by thermodilution. The exercise test will be performed at 50 % of VO2 max and hemodynamic and echocardiographic measurements will be collected. The exercise test will be performed on a supine multistage bicycle.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Diabetes Insipidus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Male Urogenital Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Cardiology, Copenhagen University Hospital, Rigshospital

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years
  • Left ventricular ejection fraction (LVEF) < 45 % on the baseline echocardiography.
  • Treatment with beta-blockers and angiotensin-converting-enzyme (ACE) inhibitors for at least 1 month as tolerated
  • New York Heart Association (NYHA) Functional Class II-III
  • Given informed consent
  • Women, who have not yet entered menopause (defined as no menstrual bleeding in the last 12 months), will provide a negative urine HCG before entering the study

Exclusion criteria

  • Signs of symptomatic or ongoing myocardial ischemia
  • Known non-revascularized coronary disease
  • Presence of hypovolemic hyponatremia (P-Na+ <130 mmol/l and clinical signs of volume depletion or dehydration as judged by investigator).
  • Hypernatraemia (P-Na+) > 145 mmol/L
  • Chronic obstructive pulmonary disease (FEV1/FVC < 70 % and/or 30 % > FEV1 < 50 %)
  • Supine systolic blood pressure < 85 mmHg
  • Significant orthostatic hypotension
  • Standing blood pressure < 80 mmHg or a blood pressure drop > 20 mmHg when changing from a supine to a standing position
  • Uncontrolled hypertension evaluated by the investigator
  • Uncontrolled cardiac arrhythmias evaluated by the investigator
  • Untreated serious hypothyroidism
  • Adrenal insufficiency
  • Poor echocardiographic window
  • Inability to perform exercise testing
  • Permanent atrial fibrillation or atrial fluttering
  • Planned coronary by-pass surgery
  • Moderate hepatic impairment (ALAT/ASAT > 3 UNL)
  • Presence of other diseases affecting treatment with conivaptan or the evaluation of safety as evaluated by the investigator
  • Severely decreased kidney function (eGFR < 20 mL/min)
  • Serum K+< 3.5 or > 5.5 mmol/L
  • Known conivaptan intolerability
  • Corn allergy
  • Dextrose Allergy
  • Treatment with potent CYP3A-inhibitors (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir)
  • Treatment with arginine vasopressin, oxytocin, desmopressin and other medications for the treatment of hyponatremia (lithium salts, urea and demeclocycline)
  • Warfarin treatment
  • Presence of infection or active bleeding

Treatment and study plan

conivaptan

Drug

Conivaptan treatment: 20 mg bolus followed by infusion of 2 mg/hour

Other names: Vaprisol

Placebo (Dextrose)

Drug

Placebo treatment: 20 mg bolus followed by infusion of 2 mg/hour

Other names: 5 % dextrose

Primary outcomes

  1. The joint endpoint of change in pulmonary capillary wedge pressure (PCWP) and cardiac output (CO) at the submaximal exercise intensity of 50 % of the maximal exercise capacity

    Time frame: 1 day

Secondary outcomes

  1. Cardiac index (CI) during submaximal exercise from rest to submaximal exercise

    Time frame: 1 day

  2. Pulmonary and systemic vascular resistance from rest to submaximal exercise

    Time frame: 1 day

  3. Left ventricular end diastolic diameter during exercise from rest to submaximal exercise

    Time frame: 1 day

  4. The change in mean pulmonary artery pressure (mPAP) from rest to submaximal exercise

    Time frame: 1 day

  5. The change in BNP, MR-ANP and copeptin from rest to submaximal exercise

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Finn Gustafsson

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 19, 2012
Registry last updated
Jun 17, 2015

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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