NCT01046838

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 24, 2012

Status Verified

May 1, 2012

Enrollment Period

2.2 years

First QC Date

January 11, 2010

Last Update Submit

May 23, 2012

Conditions

Heart Failure, Diastolic

Keywords

Diastolic Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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.

    9 weeks

Secondary Outcomes (2)

  • 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.

    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.

    9 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo 3 x daily

Drug: Placebo

sildenafil

ACTIVE COMPARATOR

40 mg sildenafil 3 x daily

Drug: Sildenafil

Interventions

SildenafilDRUG

40 mg three times daily for 9 weeks

Also known as: Revatio, Viagra
sildenafil
PlaceboDRUG

tablet 3 times daily for 9 weeks

Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

Related Publications (2)

  • Andersen MJ, Wolsk E, Bakkestrom R, Christensen N, Carter-Storch R, Omar M, Dahl JS, Frederiksen PH, Borlaug B, Gustafsson F, Hassager C, Moller JE. Pressure-flow responses to exercise in aortic stenosis, mitral regurgitation and diastolic dysfunction. Heart. 2022 Nov 10;108(23):1895-1903. doi: 10.1136/heartjnl-2022-321204.

    PMID: 36356959DERIVED

  • Andersen MJ, Ersboll M, Axelsson A, Gustafsson F, Hassager C, Kober L, Borlaug BA, Boesgaard S, Skovgaard LT, Moller JE. Sildenafil and diastolic dysfunction after acute myocardial infarction in patients with preserved ejection fraction: the Sildenafil and Diastolic Dysfunction After Acute Myocardial Infarction (SIDAMI) trial. Circulation. 2013 Mar 19;127(11):1200-8. doi: 10.1161/CIRCULATIONAHA.112.000056. Epub 2013 Feb 13.

    PMID: 23406672DERIVED

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jacob E Møller, MD, Phd, DmSci

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

  • Mads J Andersen, MD

    The Heart Center, Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD, DmSci

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 12, 2010

Study Start

December 1, 2009

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

May 24, 2012

Record last verified: 2012-05

Locations

DK(1)