NCT01960153

Brief Summary

PITCH-ER is an ancillary study of PITCH-HF (NCT01910389). The goal of the PITCH-ER ancillary study is to evaluate the rate of decline in renal function and frequency of development of acute kidney injury (AKI) in patients enrolled in PITCH-HF (who have heart failure and pulmonary hypertension) treated with chronic tadalafil treatment compared to placebo.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2013

Longer than P75 for phase_3 heart-failure

Geographic Reach
1 country

1 active site

Status
withdrawn

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

October 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

4.2 years

First QC Date

October 8, 2013

Last Update Submit

September 9, 2017

Conditions

Heart FailurePulmonary Hypertension

Keywords

Heart failurePulmonary hypertensiontadalafilPhosphodiesterase Type 5 Inhibition

Outcome Measures

Primary Outcomes (2)

  • Change in renal function

    Between-group differences in changes from baseline in: (1a) eGFR using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation and (1b) spot urine albumin-to-creatinine ratio (UACR)

    Baseline to 48 months

  • Incidence of acute kidney injury (AKI) events (clinical and subclinical)

    Impact of treatment on (2a) incidence of AKI events (adjudicated) based on new Kidney Disease Improving Global Outcomes criteria; and (2b) changes from baseline in the urine biomarkers of subclinical kidney injury: Neutrophil Gelatinase-Associated Lipocalin (NGAL) and Kidney Injury Marker 1 (KIM-1).

    Baseline to 48 months

Secondary Outcomes (2)

  • Changes in renal function stratified by diabetes/no diabetes

    Baseline to 48 months

  • Incidence of AKI events stratified by diabetes/no diabetes

    Baseline to 48 months

Study Arms (2)

Tadalafil

EXPERIMENTAL

Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.

Drug: Tadalafil

Placebo

PLACEBO COMPARATOR

Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.

Drug: Placebo

Interventions

TadalafilDRUG

Tadalafil tablets, 20 mg to 40 mg per day x 48 weeks

Also known as: Adcirca
Tadalafil
PlaceboDRUG

Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects eligible for enrollment into the PITCH-HF parent trial are eligible to enroll in this ancillary study (Refer to PITCH-HF NCT01910389 for specific eligibility criteria)

You may not qualify if:

  • Subjects who are not eligible for enrollment into the PITCH-HF parent trial may not enroll in this ancillary study (Refer to PITCH-HF NCT01910389 for specific eligibility criteria)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

MeSH Terms

Conditions

Heart FailureHypertension, Pulmonary

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesHypertensionVascular Diseases

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Ravi I Thadhani, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Ishir Bhan, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Nephrology

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 10, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2017

Study Completion

May 1, 2018

Last Updated

September 12, 2017

Record last verified: 2017-09

Locations

US(1)