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Tadalafil and Nesiritide as Therapy in Pre-clinical Heart Failure

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ClinicalTrials.gov Identifier: NCT01544998
Recruitment Status : Completed
First Posted : March 6, 2012
Results First Posted : March 4, 2015
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Horng Chen, Mayo Clinic

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition: Congestive Heart Failure
Interventions: Drug: Nesiritide
Drug: Tadalafil
Drug: Placebo
Drug: Saline load

  Participant Flow

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

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 
Overall Participants Analyzed 
[Units: Participants]
 41 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      16  39.0% 
>=65 years      25  61.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.3  (11.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      12  29.3% 
Male      29  70.7% 
Region of Enrollment 
[Units: Participants]
 
United States   41 


  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 for Preclinical Systolic Dysfunction (PSD) Reporting Group   [ Time Frame: Baseline, 60 minutes after saline load ]

4.  Secondary:   Change in Glomerular Filtration Rate (GFR) at 60 Minutes for Preclinical Diastolic Dysfunction (PDD) Reporting Group   [ Time Frame: Baseline, 60 minutes after saline load ]

5.  Secondary:   Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes for Preclinical Systolic Dysfunction (PSD) Reporting Group   [ Time Frame: Baseline, 60 minutes after saline load ]

6.  Secondary:   Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes for Preclinical Diastolic Dysfunction (PDD) Reporting Group   [ Time Frame: Baseline, 60 minutes after saline load ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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 ( U.S. NIH Grant/Contract )
5P01HL076611 ( U.S. NIH Grant/Contract )
First Submitted: January 24, 2012
First Posted: March 6, 2012
Results First Submitted: December 15, 2014
Results First Posted: March 4, 2015
Last Update Posted: March 22, 2018