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

This study has been completed.
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Jacob E Mueller, Rigshospitalet, Denmark Identifier:
First received: January 11, 2010
Last updated: May 23, 2012
Last verified: May 2012

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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SIDAMI - Sildenafil and Diastolic Dysfunction After AMI

Resource links provided by NLM:

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 ]

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 ]
  • 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 ]

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


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01046838

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jacob E Mueller, MD, PhD, DmSci, Rigshospitalet, Denmark Identifier: NCT01046838     History of Changes
Other Study ID Numbers: 2009-011006-42
Study First Received: January 11, 2010
Last Updated: May 23, 2012

Keywords provided by Rigshospitalet, Denmark:
Diastolic Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents processed this record on April 28, 2017