Tadalafil and Nesiritide as Therapy in Pre-clinical Heart Failure

This study has been completed.
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Horng Chen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01544998
First received: January 24, 2012
Last updated: October 1, 2015
Last verified: October 2015
Results First Received: December 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Congestive Heart Failure
Interventions: Drug: Nesiritide
Drug: Tadalafil
Drug: Placebo
Drug: Saline load

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited at the Mayo Clinic in Rochester, Minnesota.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2 participants in the Preclinical Systolic Dysfunction group withdrew from the study before they were randomized. No participant in the Preclinical Diastolic Dysfunction group withdrew.

Reporting Groups
  Description
Tadalafil Plus Placebo, Then Tadalafil Plus Nesiritide First intervention period: oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. There was a one week washout period. Second intervention period: oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting.
Tadalafil Plus Nesiritide, Then Tadalafil Plus Placebo First intervention period: oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. There was a one week washout period. Second intervention period: oral Tadalafil; after 1 hour, sc placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting.

Participant Flow for 3 periods

Period 1:   First Intervention (3 Hours)
    Tadalafil Plus Placebo, Then Tadalafil Plus Nesiritide     Tadalafil Plus Nesiritide, Then Tadalafil Plus Placebo  
STARTED     26     15  
COMPLETED     26     15  
NOT COMPLETED     0     0  

Period 2:   Washout (1 Week)
    Tadalafil Plus Placebo, Then Tadalafil Plus Nesiritide     Tadalafil Plus Nesiritide, Then Tadalafil Plus Placebo  
STARTED     26     15  
COMPLETED     26     15  
NOT COMPLETED     0     0  

Period 3:   Second Intervention (3 Hours)
    Tadalafil Plus Placebo, Then Tadalafil Plus Nesiritide     Tadalafil Plus Nesiritide, Then Tadalafil Plus Placebo  
STARTED     26     15  
COMPLETED     26     15  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline analysis population description includes only those subjects who completed the study.

Reporting Groups
  Description
Entire Study Population Includes groups randomized to receive Tadalafil plus Nesiritide first, and Tadalafil plus Placebo first.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  41  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     16  
>=65 years     25  
Age  
[units: years]
Mean (Standard Deviation)
  69.3  (11.9)  
Gender  
[units: participants]
 
Female     12  
Male     29  
Region of Enrollment  
[units: participants]
 
United States     41  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes for Preclinical Systolic Dysfunction (PSD) Reporting Group   [ Time Frame: Baseline, 60 minutes after saline load ]

2.  Primary:   Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes for Preclinical Diastolic Dysfunction (PDD) Reporting Group   [ Time Frame: Baseline, 60 minutes after saline load ]

3.  Secondary:   Change in Glomerular Filtration Rate (GFR) at 60 Minutes   [ Time Frame: Baseline, 60 minutes after saline load ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

4.  Secondary:   Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes   [ Time Frame: Baseline, 60 minutes after saline load ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Horng Chen, MD, Professor of Medicine
Organization: Mayo Clinic
phone: 507-284-8846
e-mail: chen.horng@mayo.edu



Responsible Party: Horng Chen, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01544998     History of Changes
Other Study ID Numbers: 11-004257
UL1RR024150 ( US NIH Grant/Contract Award Number )
Study First Received: January 24, 2012
Results First Received: December 15, 2014
Last Updated: October 1, 2015
Health Authority: United States: Food and Drug Administration