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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01046838
First Posted: January 12, 2010
Last Update Posted: May 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Jacob E Mueller, Rigshospitalet, Denmark
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (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 Jacob E Mueller, 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 11, 2010
First Posted: January 12, 2010
Last Update Posted: May 24, 2012
Last Verified: May 2012

Keywords provided by Jacob E Mueller, 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