Text Size

SIDAMI - Sildenafil and Diastolic Dysfunction After Acute Myocardial Infarction (AMI)

This study has been completed.
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Jacob E Mueller, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01046838
First received: January 11, 2010
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

In patients with Doppler echocardiographic signs of elevated LV filling pressures despite preserved LV systolic function after AMI treatment with the phosphodiesterase inhibitor sildenafil 40 mg three times daily for 9 weeks will compared with placebo

  1. Improve resting LV filling and cardiac hemodynamics.
  2. Improve exercise capacity.
  3. Improve filling pattern and cardiac hemodynamics during exercise.

Condition Intervention Phase
Heart Failure, Diastolic
 Drug: Sildenafil
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SIDAMI - Sildenafil and Diastolic Dysfunction After AMI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Among 70 patients with a recent AMI randomized to sildenafil 40 mg three times daily compared with placebo to compared Pulmonary wedge pressure, cardiac index and pulmonary artery pressure, at rest and during submaximal exercise. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Among 70 patients with a recent AMI randomized to sildenafil 40 mg three times daily compared with placebo to compared exercise capacity judged by bicycle ergometer testing. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Among 70 patients with a recent AMI randomized to sildenafil 40 mg three times daily compared with placebo to compared changes in NT-pro BNP. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: December 2009
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
placebo 3 x daily
 Drug: Placebo
tablet 3 times daily for 9 weeks
Active Comparator: sildenafil
40 mg sildenafil 3 x daily
 Drug: Sildenafil
40 mg three times daily for 9 weeks
Other Name: Revatio, Viagra

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >50 years
  • Recent AMI (within 21 days) defined according to ESC/ACC guidelines

  • Doppler echocardiographic signs of elevated filling pressures defined as

    • diastolic E/e' ratio >15, or
    • diastolic E/e' ratio 8-15 and left atrial volume index>32 ml/m2
  • Preserved LV systolic function (EF>45%)
  • Written informed consent

Exclusion Criteria:

  • Ongoing myocardial ischemia
  • Ongoing treatment with nitrates.
  • Poor echocardiographic window
  • Inability to exercise
  • Permanent atrial fibrillation or paced rhythm
  • Planned coronary artery bypass grafting
  • Other noncardiac condition with expected survival less than 6 months
  • Unwilling to participate
  • Known intolerance to sildenafil
  • Non-arteritic anterior ischaemic optic neuropathy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046838

Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Jacob E Mueller
Rigshospitalet, Denmark
Investigators
Principal Investigator: Jacob E Møller, MD, Phd, DmSci Rigshospitalet, Denmark
Principal Investigator: Mads J Andersen, MD The Heart Center, Cardiology
  More Information

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jacob E Mueller, MD, PhD, DmSci, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01046838     History of Changes
Other Study ID Numbers: 2009-011006-42
Study First Received: January 11, 2010
Last Updated: May 23, 2012
Health Authority: Denmark: The Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:
Diastolic Heart Failure

Additional relevant MeSH terms:
Heart Failure
Myocardial Infarction
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Sildenafil
 Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013