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Completed

NCT Number: NCT00376272

GISSI-AF - Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation Recurrence

Study purpose The purpose of the study is to show that the addition of valsartan on top of established therapies can reduce the recurrence of atrial fibrillation in patients with a history of recent atrial fibrillation associated with cardiovascular diseases/comorbidities.

Primary objective To demonstrate that, in patients with history of recent atrial fibrillation treated with the best recommended therapies, the addition of valsartan 320 mg is superior to placebo in reducing atrial fibrillation recurrence.

Study design The GISSI-AF is a prospective, multicenter, randomized, double blind, placebo controlled study. Patients with a history of atrial fibrillation will be centrally randomized in a 1:1 ratio to receive either valsartan or placebo.

GISSI-AF will be a pragmatic trial, with broad selection criteria to mimic real clinical practice as much as possible. Since no special examinations or procedures are required for the trial, the economic impact on the National Health Service will be minimized and use of resources likely to be optimized. The enrollment period will last 12 months. The patients will be followed up for 12 months from study entry

All prescribed treatments for AF or for the underlying cardiovascular diseases, including ACE-inhibitors, amiodarone and betablockers, will be allowed:

* patients should be on a stable treatment for at least one month * the current guideline for hypertension treatment should be applied * patients should not be started on ARBs during the study

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ospedale Valdichiana Santa Margherita, Cortona, AR, Italy

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About this study

The protocol is sponsored by an independent organization and partially supported by Novartis

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patients >=40 years of age
  • Sinus rhythm
  • At least two ECG documented episodes of symptomatic AF in the previous 6 months or After a successful cardioversion for AF performed between 14 days and 48 hours before randomization
  • At least one of the following underlying cardiovascular diseases/comorbidities:
  • heart failure/documented history of LV dysfunction (defined as an EF <40%)
  • history of hypertension >=6 months with/without LVH
  • Type II diabetes mellitus
  • documented history of stroke or peripheral vascular disease
  • documented history of coronary artery disease
  • lone atrial fibrillation with documented LA dilation (LA diameter >=45 mm for men and >=40 mm for women)
  • Written informed consent to participate in the study prior to any study procedures

Exclusion criteria

  • Need for a continuous treatment with ARBs for any clinical reasons
  • Contraindications or known hypersensitivity to ARBs
  • Persistent standing systolic blood pressure < 110 mmHg
  • Recent (<6 weeks) acute myocardial infarction or bypass surgery, or percutaneous coronary intervention
  • Clinically significant valvular etiologies
  • Thyroid dysfunction
  • Indication for pacemaker or ICD implant or for an ablative treatment, recent (<6 months) PM or ICD implant, previous ablative treatment
  • Planned cardiac surgery, expected to be performed within 3 months
  • Serum creatinine level above 2.5 mg/dL
  • Significant liver disease
  • Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception
  • Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol
  • Presence of any non-cardiac disease (e.g. cancer) that is likely to significantly shorten life expectancy
  • Treatment with any investigational agent within 1 month before randomization
  • Currently decompensated heart failure

Treatment and study plan

valsartan

Drug

Placebo

Drug

Primary outcomes

  1. To demonstrate that, in patients with history of recent AF treated with the best recommended therapies, the addition of valsartan (titrated up to 320 mg daily) is superior to placebo in reducing over the whole follow-up:

    Time frame: Time to first AF recurrence

  2. First recurrence of AF,

    Time frame: time to first AF recurrence

  3. Rate of patients with more than one AF episode,

    Time frame: end of follow-up

Secondary outcomes

  1. Number of AF episodes

    Time frame: end of fw-up

  2. Number of hospitalizations for CV reasons

    Time frame: end of fw-up

  3. Number of all-cause hospitalizations

    Time frame: end of fw-up

  4. Incidence of thromboembolic events

    Time frame: end of fw-up

  5. Number of patients who die or with non-fatal thromboembolic events

    Time frame: end of fw-up

  6. Number of patients in sinus rhythm at the time of each study visit

    Time frame: end of fw-up

  7. Number of patients in sinus rhythm who did not have any prior AF recurrence during the study

    Time frame: end of fw-up

  8. Duration and characteristics (ventricular rate) of the first recurrence of AF.

    Time frame: end of fw-up

Sponsors and collaborators

Lead sponsor

Gruppo di Ricerca GISSI

Other

Registry information

Official study title

Randomized, Prospective, Parallel Group, Placebo-Controlled, Multi-Center Study on the Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation Recurrence

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 14, 2006
Registry last updated
Apr 20, 2009

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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